Clinical trials are the key to finding out whether a traditional medicine is safe and effective in human beings.
In order for their results to be reliable and valid, clinical trials must follow good quality protocols. They must also respect national and international regulations and guidelines regarding medical ethics, patient safety and good clinical practice.
Many of these issues apply to clinical trials of any medicine, and many useful resources are to be found on Global Health Trials
However there are some issues specific to clinical trials of traditional medicines, which deserve special consideration. For example:
- What level of non-clinical information is needed to justify a trial?
- Is it ethical and scientific to observe patients who are choosing to use a particular traditional medicine?
- How to select a plant preparation, to standardise it and control its quality?
- What is the best study design?
- How can you assess efficacy of a therapy if each patient is receiving an individualised treatment?
Many of these questions depend on studies in anthropology, ethnobotany, phytochemistry, pharmacology and Intellectual Property Rights – so there are many overlaps with other “key areas” on this website.
E-learning modules on different aspects of clinical trials of herbal medicines have been developed by the University of the Western Cape in collaboration with the University of Oxford and are available here.
The panel overseeing this section of the website consists of the following experts:
Prof Gail Hughes, University of the Western Cape
Dr Nandi Siegfried, University of the Western Cape
Prof Quinton Johnson, Nelson Mandela University (George Campus)
Dr Merlin Willcox, University of Oxford
Dr Bertrand Graz, University of Lausanne